Apparatus and methods for treating intracorporeal fluid accumulation

Active Publication Date: 2012-08-16
SEQUANA MEDICAL NV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0015]The present invention overcomes the drawbacks of previously-known fluid management systems for treating ascites by providing a fluid management system that automatically and autonomously removes ascites accumulations with little patient involvement. The fluid management system of the present invention preferably comprises an implantable device including a pump, a controller, a battery and a transceiver; a charging and communication system configured to periodically charge the battery of, and communicate with, the implantable device; and monitoring and control software, suitable for use with a conventional personal computer, for configuring and controlling operation of the implantable device and charging and communication system. Preferably, the monitoring and control software is available only to the treating physician, such that the patient generally interacts with the implantable device only via the charging and communication

Problems solved by technology

Chronic ascites, pleural effusion and pericardial effusion are conditions in which chronic fluid collections persist and result in increased morbidity and mortality.
If left untreated, the fluid accumulation may interfere with proper lung function, significantly increasing morbidity and mortality.
Although a relatively simple procedure, placement of an intercostal drain is associated with a relatively high rate of major complications, including hemorrhage and infection.
However, this procedure requires a lengthy hospital stay and is reported to be associated with the onset of adult respiratory distress syndrome, a potentially life-threatening complication.
In pericardial effusion, fluid accumulates in the pericardial sac and may lead to increased intrapercardial pressure and reduced cardiac output.
Although this procedure is usually well tolerated by patients, the pericardial window may close, requiring re-operation.
Untreated ascites can result in respiratory compromise, compression of the inferior vena cava (a vital blood vessel) and spontaneous bacterial peritonitis (a life-threatening condition).
The drugs often employed to treat ascites are usually long-term and often result in complications.
The difficulty with this treatment, however, is that fluid is removed from the entire body, including the circulating volume of blood.
This in turn may result in excessive loss of fluid required to perfuse the vital organs of the human body.
Thus, even with frequent application, the medicines frequently provide unsatisfactory results.
The regular accumulation and drainage by paracentesis of large quantities of fluid in the peritoneal cavity adversely impacts patient quality of life and often can interfere with the pati

Method used

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  • Apparatus and methods for treating intracorporeal fluid accumulation
  • Apparatus and methods for treating intracorporeal fluid accumulation
  • Apparatus and methods for treating intracorporeal fluid accumulation

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first embodiment

[0048]With respect to FIG. 3A, outflow catheter 60 of the present invention is described, corresponding to bladder catheter 25 of FIG. 1. Outflow catheter 60 preferably comprises tube 61 of medical-grade silicone having inlet end 62 and outlet end 63 including spiral structure 64, and polyester ingrowth cuff 65. Outflow catheter 60 includes a single internal lumen that extends from inlet end 62 to a single outlet at the tip of spiral structure 64, commonly referred to as a “pigtail” design. Inlet end 62 may include a connector for securing the inlet end of the outflow catheter to implantable device 20, or may have a length that can be trimmed to fit a particular patient.

[0049]When configured for use as the outflow catheter in an ascites treatment system, outflow catheter may have length L3 of about 45 cm, with cuff 65 placed length L4 of about 5 to 6 cm from spiral structure 64. Outflow catheter 60 may be loaded onto a stylet with spiral structure 64 straightened, and implanted usin...

second embodiment

[0053]With respect to FIG. 3B, an outflow catheter of the present invention is described, in which similar components are identified with like-primed numbers. Outflow catheter 60′ preferably comprises tube 61′ of medical-grade silicone having inlet end 62′, outlet end 63′ and polyester ingrowth cuff 65′. In accordance with this embodiment, outlet end 63′ includes malecot structure 66, illustratively comprising four resilient wings 67 that expand laterally away from the axis of the catheter to reduce the risk that outlet end 63′ of the catheter will be inadvertently pulled loose after placement. Inlet end 62′ may include a connector for securing the inlet end of the outflow catheter to implantable device 20, or may have a length that can be trimmed to fit a particular patient.

[0054]Malecot structure 66 preferably is constructed so that wings 67 deform to a substantially flattened configuration when a stylet is inserted through the lumen of the catheter. In this manner, outflow cathet...

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Abstract

A fluid management system for the treatment of ascites, pleural effusion or pericardial effusion is provided including an implantable device including a pump, control circuitry, battery and transceiver; a charging and communication system configured to periodically charge the battery and communicate with the implantable device to retrieve performance data; and monitoring and control software, suitable for use with conventional personal computers, for configuring and controlling operation of the implantable device and charging and communication system. The implantable device includes a number of features that provide automated movement of fluid to the bladder with reduced risk of clogging, with no patient involvement other than occasional recharging of the battery of the implantable device. The monitoring and control software is available only to the treating physician, such that the physician interacts with the implantable device via the charging and communication system.

Description

I. CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims the benefit of U.S. Provisional Patent Application No. 61 / 443,668, filed Feb. 16, 2011 and entitled “Apparatus and Methods for Treating Intracorporeal Fluid Accumulation,” the entire contents of which are incorporated herein by reference.II. FIELD OF THE INVENTION[0002]This application relates to apparatus and methods for treating intracorporeal fluid accumulations, such ascites, pleural effusion and pericardial effusion.III. BACKGROUND OF THE INVENTION[0003]There are a variety of conditions which result in pathologic chronic collection of bodily fluids within the peritoneum, pleura or pericardial sac. Chronic ascites, pleural effusion and pericardial effusion are conditions in which chronic fluid collections persist and result in increased morbidity and mortality.[0004]These foregoing conditions currently are treated typically by one of three methods: 1) external drainage, which poses a risk of infection and lo...

Claims

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Application Information

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IPC IPC(8): A61M1/00A61B5/08G16H40/63
CPCA61M5/14276A61M27/002A61M2205/3507A61M2205/8243A61M5/14236G06F19/3468A61M2205/3569A61M1/0023A61M2205/04A61M2205/33A61M2205/18A61M2205/8237A61M2205/8206A61M2210/1017A61M2210/101A61M2210/122A61M2210/1085A61M1/84A61M1/28G16H40/63A61M2205/10A61M2205/3368A61M2205/3379A61M2205/502A61M2205/52A61M2230/005A61M2230/42G16H20/17
Inventor DEGEN, THOMAS WERNERTHOMMEN, DANIEL THOMASJOHNSON, NOEL L.
Owner SEQUANA MEDICAL NV
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